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Can Commun Dis Rep. 2021 Oct 14; 47(10): 422–429. Published online 2021 Oct 14.
doi: 10.14745/ccdr.v47i10a04
PMCID: PMC8525605PMID: 34737674
Influenza Vaccine
Surveillance of laboratory exposures to human pathogens and toxins, Canada 2020
Nicole Atchessi, 1 Megan Striha, 1 Rojiemiahd Edjoc, 1 ,* Emily Thompson, 1 Maryem
El Jaouhari, 1 and Marianne Heisz 1
Author information Copyright and License information Disclaimer
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Abstract
Background
The Laboratory Incident Notification Canada surveillance system monitors laboratory
incidents reported under the Human Pathogens and Toxins Act and the Human Pathogens
and Toxins Regulations. The objective of this report is to describe laboratory
exposures that were reported in Canada in 2020 and the individuals who were
affected.

Methods
Laboratory incident exposures occurring in licensed Canadian laboratories in 2020
were analyzed. The exposure incident rate was calculated and the descriptive
statistics were performed. Exposure incidents were analyzed by sector, activity
type, occurrence type, root cause and pathogen/toxin. Affected persons were
analyzed by education, route of exposure sector, role and laboratory experience.
The time between the incident and the reporting date was also analyzed.

Results
Forty-two incidents involving 57 individuals were reported to Laboratory Incident
Notification Canada in 2020. There were no suspected or confirmed laboratory
acquired infections. The annual incident exposure rate was 4.2 incidents per 100
active licenses. Most exposure incidents occurred during microbiology activities
(n=22, 52.4%) and/or were reported by the hospital sector (n=19, 45.2%). Procedural
issues (n=16, 27.1%) and sharps-related incidents (n=13, 22.0%) were the most
common occurrences. Most affected individuals were exposed via inhalation (n=28,
49.1%) and worked as technicians or technologists (n=36, 63.2%). Issues with
standard operating procedures was the most common root cause (n=24, 27.0%),
followed by human interactions (n=21, 23.6%). The median number of days between the
incident and the reporting date was six days.

Conclusion
The rate of laboratory incidents were lower in 2020 than 2019, although the ongoing
pandemic may have contributed to this decrease because of the closure of non-
essential workplaces, including laboratories, for a portion of the year. The most
common occurrence type was procedural while issues with not complying to standard
operating procedures and human interactions as the most cited root causes.

Keywords: laboratory exposures, laboratory incidents, laboratory-acquired


infections, human pathogens and toxins, surveillance, Laboratory Incident
Notification Canada, Centre for Biosecurity
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Introduction
Laboratory work with human pathogens and toxins (HPTs) poses an inherent risk to
the security of laboratory personnel. While safety practices and regulations of
HPTs have evolved considerably over the years, accidental or deliberate exposure to
human pathogens and toxins in laboratory settings remain a biosafety and
biosecurity concern, both within Canada and abroad.

In response to the reporting requirements for incidents involving HPTs outlined by


the 2009 Human Pathogens and Toxins Act (HPTA) ((1)), the Laboratory Incident
Notification Canada (LINC) surveillance system was launched in December 2015. The
LINC system is unique in that it is one of the first comprehensive national
surveillance systems to provide a systematic framework for reporting HPT exposures
and laboratory-acquired infections (LAIs) across various settings. A total of 247
exposure incidents have been reported between 2016 and 2019, involving a total of
539 individuals among private, public, hospital, and academic sector laboratories (
((2–5))). In contrast, national reporting requirements for LAIs among other
countries is often voluntary or conducted via retrospective survey ( ((6–9))).

The Public Health Agency of Canada’s Centre for Biosecurity is mandated to protect
the health and safety of the public against risks posed by HPTs through the
administration and enforcement of the HPTA and the Human Pathogen and Toxins
Regulations (HPTR). Under the HPTA, all Canadian laboratory facilities conducting
controlled activities with HPTs are required to obtain a license, unless otherwise
exempted. Under the HPTA, all licensed facilities are required to report laboratory
incidents involving risk group 2 (RG2) pathogens or above in the following
instances:

Exposures and laboratory-acquired infections/intoxication


Inadvertent release, production, or possession of an HPT
Missing, stolen or lost HPT, including security sensitive biological agents (SSBA)
not received within 24 hours of the expected date and time of receipt
Changes in biocontainment
Canadian Biosafety Standard (CBS) Second Edition categorizes pathogens among four
RGs, dependent upon a pathogen’s risk to the individual and to the community
((10)). The RG2 pathogens pose a low risk to public health, but a moderate risk to
an individual’s health. These pathogens can cause serious disease in humans but are
unlikely to do so. The RG3 pathogens pose a low risk to public health, but a high
risk to an individual’s health, and are likely to cause serious disease in humans.
Finally, RG4 pathogens pose a high risk to both public and individual health and
are likely to cause serious disease in humans that often leads to death.

The 2020 Annual Report marks the fifth year of the program and would normally be
the year at which a baseline on incident reporting is established. However, due to
the unprecedented response to the severe acute respiratory syndrome coronavirus 2
(SARS-CoV-2) pandemic by the Public Health Agency of Canada and the associated
resource re-allocation, the development of a baseline will occur in the 2022 annual
report, to be released in 2023.

As with previous years, this annual report aims to describe the distribution of
laboratory incidents reported to LINC across years with special attention to
exposures, LAIs and factors associated with these exposures at the license (by
sector of exposures, HPT, occurrence type) and person (number of affected persons,
education, main role, type of activity, years of experience, route of exposure,
root causes) level.

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Methods
Data sources
The Biosecurity Portal, LINC’s external interface, receives notification and
follow-up report(s) of laboratory incidents, which are then captured by the
internal Customer Relationship Management system. For this report, exposure
incidents that took place from January 1, 2020 to December 31, 2020 were extracted
from the Customer Relationship Management system. Incidents that did not have a
known occurrence date were also included if they were reported during this period.
Data of the most recent follow-up reports were used for analysis, while the data of
initial reports were used where corresponding follow-up reports and/or data were
not present as of the data extraction date, February 8, 2021. Extracted data were
cleaned by investigation of any outliers and removal of duplicate entries. It
should be noted that while licensed facilities are obligated to report laboratory
incidents, the rate of non-reporting is currently unknown and a confounder in this
analysis.

Within the scope of the HPTA/HPTR, an exposure incident was defined as a laboratory
incident that may have resulted in intoxication/infection or had resulted in
suspected or confirmed LAI ((1,10)). A non-exposure incident referred to
inadvertent possession or production of an HPT that is a higher RG than the lab is
licensed to work with, release of a pathogen or toxin (to which no laboratory
personnel are exposed), or a missing, lost or stolen pathogen or toxin or a
security-sensitive biological agent not being received within 24 hours of expected
arrival.

Analysis
Data from reports submitted to the LINC surveillance system were extracted to
Microsoft Excel 2016 for analysis and R 4.0.2 was used to perform descriptive
statistics with cross-validation using SAS EG 7.1. All exposure incidents were
first subdivided into ruled out incidents and confirmed incidents, with confirmed
and suspected LAIs included in the latter. Reports can be ruled out for a variety
of reasons, including if no exposure was found to have occurred, if the exposure
involved an RG1 HPT or an HPT in its natural environment such as a primary specimen
(neither are mandated by the HPTA and these reports are considered voluntary) or if
duplicate reports are received. Affected persons in confirmed incidents were also
subdivided into confirmed or ruled out individuals. Among confirmed exposure
incidents, the numbers of incidents were analyzed against parameters obtained at
two levels of reporting. At the level of the active license holder, the
distributions of incidents by sector, main activity, root cause, occurrence type,
and implicated pathogen/toxin reported were examined as well as reporting delays.
At the level of persons affected in these incidents, the distributions of their
highest level of education, years of experience, route of exposure, sector and
regular role were examined. Particular attention was given to exposures involving
SARS-COV-2 because of its status as an emerging pathogen and its role in the
ongoing coronavirus disease 2019 (COVID-19) pandemic.

A comparison of exposure incidents and a measure of the exposure incident rate per
100 active licenses from 2016 to 2020 were also performed. The incident rate was
described in greater detail in a previous report ( ((5))). Active licenses are
licenses that were considered active during 2020 and were able to report an
incident. Given the unavailability of the number of active licenses for December
31, 2020 owing to the impact of the pandemic on normal operations, and given the
low fluctuation over the year (25–50 licenses each year), the number of active
licenses on April 2020 was used for the calculation of the exposure incidence rate.
The median time between the date of occurrence and the date of submission of the
exposure incidents was also calculated. Median values were chosen compared to mean
values owing to the presence of extreme outliers.

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Results
Between January 1, 2020 and December 31, 2020, LINC received 96 laboratory incident
reports: 56 exposure reports, 27 non-exposure reports and 13 other reports (Figure
1). All 13 other reports described changes within the laboratory that could affect
biocontainment. There were 14 exposure reports and one non-exposure report ruled
out, leaving 42 exposure incidents and 26 non-exposure incidents (Figure 2). There
were no suspected or confirmed LAIs in 2020. From the exposure reports, 79 people
were identified as having been exposed in laboratory incidents. Upon further
investigation, 22 of those people were ruled out, leaving a total of 57 exposed
people in 2020.

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Figure 1
Types of incidents reported to Laboratory Incident Notification Canada and exposure
incidents included in analysis, Canada 2020

Abbreviations: LAIs, laboratory-acquired infections; LINC, Laboratory Incident


Notification Canada

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Figure 2
Confirmed exposure incidents, suspected and confirmed laboratory acquired
infections and active licenses, Canada 2016–2020

Abbreviation: LAIs, laboratory-acquired infections

There were 999 active licenses held in Canada permitting the use of HPTs in 2020.
The exposure incident rate was 4.2 incidents per 100 active licenses in 2020. The
total number of incidents and the rate of incidents per 100 active licenses was
lower in 2020 than in 2019 (60 exposure incidents and 6.0 per 100 active licenses)
(Figure 2).

Exposure incidents by main activity and sector


Microbiology was the most common activity being performed during exposure incidents
(n=22, 52.4%), followed by in vivo animal research (n=5, 11.9%). Other activities
include cell culture, autopsy/necropsy, maintenance, animal care, molecular
investigation, microscopy or other (n=15, 35.7%). Definitions of activities are
available in Appendix A1.

Most exposure incidents occurred in the hospital sector (n=19, 45.2%) followed by
the academic sector (n=16, 38.1%) (Figure 3). The hospital sector had the highest
number of exposure incidents per 100 active licenses (10.4 per 100), while the
environmental health sector had the lowest with no incidents reported in 2020.

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Figure 3
Confirmed exposures incidents and active licenses by sector reported to Laboratory
Incident Notification Canada, Canada 2020

Implicated human pathogens and toxins


Among the 42 implicated biological agents, most were non-SSBA (n=37, 88.1%) and
human risk group 2 (n=23, 54.8%) (Table 1). Bacteria were the most commonly
implicated agent (n=17, 40.5%), while parasites and prions were the least
frequently implicated (n=1, 2.3% each). Neisseria meningitidis was the most common
RG2 agent (n=6, 14.3%), followed by lentiviral vectors (n=3, 7.1%). Blastomyces
(Ajellomyces) dermatitidis was the most common RG3 agent (n=7, 16.7%), followed by
SARS-CoV-2 (n=4, 9.5%) (data not shown).

Table 1
Human pathogens or toxins involved in reported exposure incidents by risk group
level and security sensitive status, Canada 2020 (N=42)
Biological agent type by risk group Non-SSBA SSBA Total
n % n % n %
RG2 23 55 0 0 23 55
Bacteria 12 29 0 0 12 29
Fungus 0 0 0 0 0 0
Parasite 1 2 0 0 1 2
Prion 1 2 0 0 1 2
Toxin 3 7 0 0 3 7
Virus 6 14 0 0 6 14
Unknown 0 0 0 0 0 0
RG3 14 33 4 10 18 43
Bacteria 2 5 3 7 5 12
Fungus 7 17 1 2 8 19
Parasite 0 0 0 0 0 0
Prion 0 0 0 0 0 0
Toxin 0 0 0 0 0 0
Virus 5 12 0 0 5 12
Unknown 0 0 0 0 0 0
Unknown 0 0 0 0 1 2
Bacteria 0 0 0 0 0 0
Fungus 0 0 0 0 0 0
Parasite 0 0 0 0 0 0
Prion 0 0 0 0 0 0
Toxin 0 0 0 0 0 0
Virus 0 0 0 0 0 0
Unknown 0 0 0 0 1 2
Total 37 88 4 10 42 100
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Abbreviations: RG2, risk group 2; RG3, risk group 3; SSBA, security sensitive
biological agents

Occurrence types
The 42 exposure reports cited 58 incident occurrence types. Procedural (n=16,
27.1%) and sharps-related incidents (n=13, 22.0%) were the most common (Figure 4).
Definitions are given in Appendix B1.

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Figure 4
Reported occurrence types involved in reported exposure incidents, Canada 2020
(N=58)

Abbreviation: PPE, personal protective equipment

Exposed individuals
In total, 57 individuals were exposed through the 42 confirmed exposure reports.
Most exposed individuals had a technical or trades college diploma as their highest
level of education (n=24, 42.1%), followed by a Bachelor’s degree (n=12, 21.1%) or
a Master’s degree (n=11, 19.3%). Other highest levels include high school (n=2,
3.5%), a MD/PhD (n=1, 1.8%) and a postdoctoral fellow (n=1, 1.8%). The remaining
six individuals had other (n=3, 5.3%) or unknown (n=3, 5.3%) highest level of
education (data not shown).

Consequently, most of the exposed individuals worked as technicians or


technologists (n=36, 63.2%), students (n=9, 15.8%) and researchers (n=4, 7.0%). One
exposed person was a supervisor or manager (1.8%), and the rest had other roles
(n=7, 12.3%) (Figure 5).
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Figure 5
Individuals affected in exposure incidents reported by number of years of
laboratory experience and main rolea, Canada 2020 (N=57)

Among the 57 exposed individuals (not shown), most were exposed through inhalation
(n=32, 56.1%) or sharps (n=9, 15.8%). Other routes of exposure include absorption
(n=3, 5.3%) and ingestion (n=2, 3.5%). The rest were other (n=11, 19.3%) routes of
exposure (data not shown).

Root causes and areas for laboratory safety improvement


In total, there were 89 root causes identified in the 42 exposure reports (Table
2). Issues with standard operating procedures (SOP) was the most common root cause
(n=24, 27.0%), followed by human interactions (n=21, 23.6%) and equipment issues
(n=12, 13.5%).

Table 2
Root causes reported in follow-up reports of exposure incidents, Canada 2020 (N=89)
Root cause Examples of areas of concern Citations
n %a
Communication Communication did not occur but should have 8 9
Communication was unclear, ambiguous, etc.
Equipment Equipment quality control needed improvement 12 13
Equipment failed
Equipment was not appropriate for purpose
Human interaction A violation (cutting a corner, not follow correct procedure,
deviating from standard operating procedure) 21 24
An error (a mistake, lapse of concentration, or slip of any kind)
Management and oversight Supervision needed improvement 10 11
Lack of auditing of standards, policies and procedures
Risk assessment needed improvement
Training Training not in place but should have been in place 9 10
Training not appropriate for task/activity
Staff were not qualified or proficient in performing task
Standard operating procedure Documents were followed as written but not correct
for activity/task 24 27
Procedures that should have been in place were not in place
Documents were not followed correctly
Other Not applicable 5 6
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a Percentages rounded to the nearest whole number

Time between the incident and the reporting date


Exposure incident reports are to be submitted to LINC without delay. In 2020, of
the 41 incident exposure reports that included the incident date, 23 (56.1%) were
submitted to LINC within one week of the incident. The median number of days
between the incident and the reporting date was six days in 2020, up slightly from
a median of four days in 2019 (Figure 6).

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Figure 6
Time between the date of the incident and the date report was submitted to
Laboratory Incident Notification Canada, Canada 2016–2020

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Discussion
In 2020, 42 laboratory exposures to HPTs had been reported to LINC, a decrease from
the 60 reported in 2019. The reports did not include any LAI and were submitted
within a median delay of six days. Reports on RG2, non-SSBA agents as well as
bacteria were the most common types of HPTs involved in exposure incidents.
Neisseria meningitides and lentiviral vector exposures were more common among RG2
HPTs, whereas Blastomyces (Ajellomyces) dermatitidis and SARS-CoV-2 exposures were
more common among RG3.

Similar to 2019, exposures were mainly due to procedure breaches and sharps, and
occurred mostly in academic and hospital sectors while performing microbiology
activities. In total, 57 individuals, predominantly technicians or technologists,
were exposed to an HPT. Lack of awareness or compliance with standard operating
procedures and human interactions were the main root causes identified.

Number of exposures and exposure incident rate have followed the same trend over
the past five years
At the onset of the LINC program in 2016, the number of exposure incidents reported
had increased, with a peak reached in 2018. The increase was concomitant to the
rise of the number of licenses granted to laboratories over the same period. After
2018, despite the number of licenses remaining stable, the number of incidents
started to decrease. The exposure incident rate followed a trend similar to the
number of licenses, meaning that the increase from 2016 to 2018 and the decrease
from 2018 to 2020 were not due to a change in the number of licenses granted to
laboratories. The initial rise of the exposure incident rate from 2016 to 2018 was
likely the result of the actions engaged by the LINC surveillance system to
facilitate reporting and enhance clarity on regulatory requirements (5))).
Regarding the decrease from 2018 to 2020, when an exposure incident occurs in a
licensed laboratory, an incident response is actioned by the Centre for Biosecurity
with the final goal of identifying root causes and encouraging corrective actions.
This feedback may have raised the awareness of licensed parties and may be
partially responsible for the decline in reports in recent years. Further
information on incident reporting specifics can be found in the incident reporting
guidelines published in 2017 ((11)). In addition, stay at home orders and other
pandemic responses likely led to a reduction in laboratory activities for a portion
of 2020, possibly leading to fewer reports.

Exposure incidents involving SARS-CoV-2 reported to Laboratory Incident


Notification Canada did not include exposure incidents occurring during diagnostic
activities
The reporting of exposure incidents in a laboratory setting through activities
involving HPTs in their natural environment is not mandatory under the HPTA.
Pathogens and toxins are considered to be in their natural environment if they are
collected directly from humans or animals (e.g. blood, serum, tissue, urine, feces,
saliva, milk, etc.) or from the environment (e.g. water, soil). Consequently,
exposure incidents occurring during diagnostic activities involving SARS-CoV-2 were
not systematically reported to LINC and were not included in this report. Four of
the 42 exposure incidents reported to LINC involved SARS-CoV-2. These incidents
occurred during research activities and were therefore mandatory. Although such
reporting was voluntary, laboratory workers are encouraged to report exposure
incidents involving HPTs in the HPTs’ natural environment. This reporting enables
the collection of data at the national level that can be used to detect real-time
trends and potential patterns of concern, and to facilitate early responses in
order to prevent and/or mitigate biosafety risks.

Delay of notification of exposure incidents has improved over the past five years
According to the Notification and Reporting under the HPTA and HPTR Guidelines and
the HPTA, notification reports of exposure incidents have to be submitted to LINC
without delay ((11)). From 2016 to 2019, the median time of submission of exposure
incidents decreased from two weeks to four days. Such a decrease maybe explained by
the LINC surveillance system actions to facilitate reporting and inform
laboratories regarding submission timeliness recommendations. However, in the past
year (2020), the median time of report submission increased slightly, from four to
six days. This change was possibly attributable to an increase of the workload of
laboratories and to disruptions of work caused by the ongoing pandemic. A
comparison of time of submission was not done internationally, since exposure
reports in other countries were done on a voluntary basis or through surveys
( ((8,12,13))).

Strengths and limitations


The main strength of this study is the centralized and mandatory reporting process
of laboratory incidents in laboratories across Canada. Further, the LINC allows for
an almost real-time identification of causes of incidents and potential areas of
improvement that could be addressed in conjunction with laboratories to ensure
risks are mitigated in a timely manner. For example, the most exposed individuals
were found to be technicians, due to lack of compliance to SOPs. This information
could be used by licensed facilities to examine current protocols that are related
to SOP compliance to reduce the risk of exposures of laboratory workers in the
future. Newsletters ( ((14) and e-blasts prepared by the LINC team discuss common
safety issues and areas for improvement as they arise, which are shared with
stakeholders. In addition, there is constant communication between the Centre for
Biosecurity and regulated parties. Further follow-up with regulated parties are
planned to communicate these results to ensure incidents involving SOP compliance
are addressed and adhered to.

There are several limitations of this study. First, non-reporting is a possible


confounder in this analysis. The magnitude and significance of non-reporting is
currently unmeasured; however, we continually encourage license holders to report
laboratory exposure incidents without delay. Second, the exclusion of reports with
missing dates from the analysis of the “time to reporting” calculation is another
limitation. Given that the proportion of missing values was lower than 10%, the
estimation of the median time to reporting likely had only a minor impact. Another
limitation is that the number of licenses was used as a proxy of the laboratory
workforce for the calculation of the exposure incidence rate ( ((5))). Further, the
number of active licenses from December 2020 was unavailable due to the effects of
the pandemic. Instead, the number of active licenses for April 2020 was used, as
the number of licenses usually fluctuates minimally throughout the year. We will
continue to address these limitations through constant communication with
stakeholders, by ways of newsletters and e-blasts and biosafety advisories.

Conclusion
The rate of laboratory exposure incidents was lower in 2020 than 2019. The ongoing
pandemic may have contributed to this decrease because of the closure of
laboratories (and other non-essential workplaces) for a portion of the year. The
most common occurrence type was procedural, while issues with non-compliance with
SOP and human interactions were the most cited root causes.

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Acknowledgements
We would like to express our gratitude to our regulated parties for their continued
support and contribution regarding incident reporting across Canada. We would also
like to say a special thanks to the staff of the Centre of Biosecurity for their
continued input, support and expertise.

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Appendix A1.  Definitions of main activity
Main activity Definition
Animal care Activities such as attending to the daily care of animals and providing
animals with treatment
Autopsy or necropsy Post-mortem surgical examinations for purposes such as
determining cause of death or to evaluate disease or injury for research or
educational purposes
Cell culture The process of growing cells under controlled conditions; it can
also involve the removal of cells from an animal or plant
Education or training Education or training of students and/or personnel on
laboratory techniques and procedures
In vivo animal research Experimentation with live, non-human animals
Maintenance The upkeep, repair, and/or routine and general cleaning of equipment
and facilities
Microbiology Activities involving the manipulation, isolation, or analysis of
microorganisms in their viable or infectious state
Molecular investigations Activities involving the manipulation of genetic
material from microorganisms or other infectious material for further analysis
Serology Diagnostic examination and/or scientific study of immunological
reactions and properties of blood serum
Hematology Scientific study of the physiology of blood
Open in a separate window
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Appendix B1.  Definitions of occurrence type
Occurrence type Definition
Spill Any unintended release of an agent from its container
Loss of containment Includes malfunction or misuse of containment devices or
equipment and other type of failures that results in the agent being spilled
outside of, or released from containment
Sharps-related Needle stick, cut with scalpel, blade or other sharps injury
(i.e. broken glass)
Animal-related Includes animal bites or scratches, as well as other exposure
incidents resulting from animal behavior (i.e. animal movement resulting in a
needle stick)
Insect-related Includes insect bites
PPE-related Includes either inadequate PPE for the activity or failure of the PPE
in some way
Equipment-related Includes failure of equipment, incorrect equipment for the
activity, or misuse of equipment
Procedure-related Includes instances when written procedures were not followed,
were inadequate or absent, or were incorrect for the activity
Open in a separate window
Abbreviation: PPE, personal protective equipment

Competing interests: None.

Funding: None.

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https://www.canada.ca/en/services/health/biosafety-biosecurity/newsletter.html
Articles from Canada Communicable Disease Report are provided here courtesy of
Public Health Agency of Canada
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